Test Catalog

Test Id : CRHEP

Chronic Hepatitis (Unknown Type), Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosis and evaluation of patients with symptoms of hepatitis with a duration more than 6 months

 

Distinguishing between chronic hepatitis B and chronic hepatitis C

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
HBC HBc Total Ab, S Yes Yes
HBAB HBs Antibody, S Yes Yes
HBAG HBs Antigen, S Yes Yes
HCVDX HCV Ab w/Reflex to HCV PCR, S Yes Yes

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
HCVQN HCV RNA Detect/Quant, S Yes No
HBGNT HBs Antigen Confirmation, S No No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis C virus (HCV) antibody is reactive, then HCV RNA detection and quantification by real-time reverse transcription polymerase chain reaction will be performed at an additional charge.

 

If hepatitis B surface antigen is reactive, then confirmation will be performed at an additional charge.

 

The following algorithms are available:

-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

-Viral Hepatitis Serologic Profiles

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Chemiluminescence Immunoassay (CIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Chronic Hepatitis Profile

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis C virus (HCV) antibody is reactive, then HCV RNA detection and quantification by real-time reverse transcription polymerase chain reaction will be performed at an additional charge.

 

If hepatitis B surface antigen is reactive, then confirmation will be performed at an additional charge.

 

The following algorithms are available:

-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

-Viral Hepatitis Serologic Profiles

Specimen Type
Describes the specimen type validated for testing

Serum SST

Necessary Information

Date of draw is required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 3 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into plastic vial.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send 1 of the following:

-Gastroenterology and Hepatology Client Test Request (T728)

-Infectious Disease Serology Test Request (T916)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

2.75 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Heat-inactivated specimen Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 28 days
Refrigerated 5 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Diagnosis and evaluation of patients with symptoms of hepatitis with a duration more than 6 months

 

Distinguishing between chronic hepatitis B and chronic hepatitis C

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If hepatitis C virus (HCV) antibody is reactive, then HCV RNA detection and quantification by real-time reverse transcription polymerase chain reaction will be performed at an additional charge.

 

If hepatitis B surface antigen is reactive, then confirmation will be performed at an additional charge.

 

The following algorithms are available:

-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

-Viral Hepatitis Serologic Profiles

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Hepatitis B:

Hepatitis B virus (HBV) is a DNA virus that is endemic throughout the world. The infection is spread primarily through percutaneous contact with infected blood products (eg, blood transfusion, sharing of needles by drug addicts). The virus is also found in virtually every type of human body fluid and is known to be spread through oral and genital contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions; it is not commonly transmitted transplacentally.

 

After a course of acute illness, HBV persists in approximately 10% of patients. Some of these carriers are asymptomatic; others develop chronic liver disease including cirrhosis and hepatocellular carcinoma.

 

Hepatitis C:

Hepatitis C virus (HCV) is an RNA virus that is a significant cause of morbidity and mortality worldwide. HCV is transmitted through contaminated blood or blood products or through other close, personal contacts. It is recognized as the cause of most cases of post-transfusion hepatitis. HCV shows a high rate of progression (>50%) to chronic disease. In the United States, HCV infection is quite common, with an estimated 3.5 to 4 million chronic HCV carriers. Cirrhosis and hepatocellular carcinoma are sequelae of chronic HCV.

 

The following algorithms are available:

-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination

-Hepatitis B: Testing Algorithm for Screening, Diagnosis, and Management

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

-Viral Hepatitis Serologic Profiles

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

HEPATITIS B SURFACE ANTIGEN :

Negative

 

HEPATITIS B SURFACE ANTIBODY, QUALITATIVE/QUANTITATIVE

Hepatitis B Surface Antibody

Unvaccinated: negative

Vaccinated: positive

 

Hepatitis B Surface Antibody, Quantitative

Unvaccinated: <5.0 mIU/mL

Vaccinated: > or =12.0 mIU/mL

 

HEPATITIS B CORE TOTAL ANTIBODIES:

Negative

 

HEPATITIS C ANTIBODY:

Negative

 

Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles in Special Instructions.

Interpretation
Provides information to assist in interpretation of the test results

Interpretation depends on clinical setting. See Viral Hepatitis Serologic Profiles

 

Chronic Hepatitis B:

Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum 6 to 16 weeks following hepatitis B viral (HBV) infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms. Persistence of HBsAg for more than 6 months indicates development of either a chronic carrier state or chronic HBV infection.

 

Hepatitis B core antibodies (anti-HBc Ab) appear shortly after the onset of symptoms of HBV infection and soon after the appearance of HBsAg. The IgM subclass usually falls to undetectable levels within 6 months, and the IgG subclass may remain for many years.

 

Hepatitis B surface antibody (anti-HBs) usually appears with the resolution of hepatitis B virus infection after the disappearance of HBsAg.

 

If HBsAg and anti-HBc (total antibody) are positive and patient's condition warrants, consider testing for hepatitis Be antigen (HBeAg), anti-HBe, hepatitis B virus DNA (HBV-DNA) or anti-hepatitis D virus (anti-HDV).

 

Chronic Hepatitis C:

Anti-HCV is almost always detectable by the late convalescent and chronic stage of infection.

 

The serologic tests currently available do not differentiate between acute and chronic hepatitis C infections.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Positive hepatitis B surface antigen (HBsAg) test results should be reported by the attending physician to the State Department of Health as required by law in some states.

 

Consider administration of hepatitis B immune globulin (HBIG) and hepatitis B vaccine to HBsAg antibody negative individuals exposed to the HBsAg-positive patient's blood or body fluids.

 

Neonates (<1 month old) with positive hepatitis B core (anti-HBc) total antibody results from this assay method should be tested for anti-HBc IgM antibody to rule-out possible maternal anti-HBc total antibody causing false-positive results. Repeat testing for anti-HBc total antibody within 1 month is also recommended in these anti-HBc total antibody-positive neonates.

 

Assay performance characteristics have not been established for:

-Individuals under 10 years of age for HCVDX / Hepatitis C Virus (HCV) Antibody with Reflex to HCV RNA, PCR, Symptomatic, Serum

-Grossly icteric (total bilirubin level of >20 mg/dL)

-Grossly lipemic (triolein level of >3000 mg/dL)

-Grossly hemolyzed (hemoglobin level of >500 mg/dL)

-Cadaveric specimens

-Those that contain particulate matter

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Wietzke P, Schott P, Braun F, Mihm S, Ramadori G: Clearance of HCV RNA in a chronic hepatitis C virus-infected patient during acute hepatitis B virus superinfection. Liver. 1999 Aug;19(4):348-353

2. Villari D, Pernice M, Spinella S, et al: Chronic hepatitis in patients with active hepatitis B virus and hepatitis C virus combined infections: a histological study. Am J Gastroenterol. 1995 Jun;90(6):955-958

3. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF: Diagnostic markers of chronic hepatitis B infection and disease. Antivir Ther. 2010;15(Suppl 3):35-44

4. American Association for the Study of Liver Diseases and Infectious Diseases Society of America: HCV guidance: Recommendations for testing, managing, and treating hepatitis C. Accessed September 29, 2020. Available at www.hcvguidelines.org/content

5. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol. 2001 Jun;21(3):229-237

6. LeFebre ML, US Preventive Services Task Force: Screening for hepatitis B virus infection in nonpregnant adolescents and adults: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Jul 1;161(1):58-66. doi: 10.7326/M14-1018

7. Jackson K, Locarnini S, Gish R: Diagnostics of hepatitis B virus: Standard of care and investigational. Clin Liver Dis (Hoboken). 2018 Aug 22;12(1):5-11. doi: 10.1002/cld.729

8. Coffin CS, Zhou K, Terrault NA: New and old biomarkers for diagnosis and management of chronic hepatitis B virus infection. Gastroenterology. 2019 Jan;156(2):355-368.e3. doi: 10.1053/j.gastro.2018.11.037

9. WHO Guidelines Development Group: World Health Organization Guidelines on hepatitis B and C testing. World Health Organization; 2017. Accessed September 29, 2020. Available at www.who.int/hepatitis/publications/guidelines-hepatitis-c-b-testing/en/

10. Centers for Disease Control and Prevention. Testing and public health management of persons with chronic hepatitis B virus infection. Accessed April 8, 2020. Available at www.cdc.gov/hepatitis/hbv/testingchronic.htm

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

Hepatitis B Surface Antigen:

Specimens are first tested by the VITROS hepatitis B surface antigen (HBsAg) assay. With modification to the assay manufacturer's instructions for use, specimens yielding signal-to-cutoff (S/Co) of 1.00 or greater but 100.0 or less will be confirmed by the VITROS HBsAg Confirmatory assay. Specimens that are strongly positive (ie, S/Co >100.0) do not require this confirmation. This immunometric technique involves the simultaneous reaction of HBsAg in the sample with mouse monoclonal hepatitis B surface antibody (anti-HBs) coated onto the wells and a horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HBs antibody in the conjugate. Unbound conjugate is removed by washing. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the instrument. The amount of HRP conjugate bound is indicative of the level of HBsAg present in the sample.(Package insert: VITROS HBsAg assay, no. GEM1201_US_EN. Ortho-Clinical Diagnostics, Inc; V 13.1, 09/06/2019)

 

HBsAg Confirmation:

The VITROS HBsAg Confirmatory Kit uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The sample is tested twice: 1 aliquot is incubated with a neutralizing reagent containing high titer anti-HBs (the confirmatory antibody); the second aliquot is incubated with a non-neutralizing control reagent (the sample diluent). The confirmatory antibody binds to HBsAg in the sample inhibiting its reaction in the VITROS HBsAg assay. This leads to a reduced result compared to that for the non-neutralized control sample.(Package insert: VITROS HBsAg Confirmation assay, no. GEM4201_US_EN. Ortho-Clinical Diagnostics, Inc; V 13.1, 09/06/2019)

 

HBs Antibody:

This chemiluminescent immunoassay is based on an immunometric technique in which the anti-HBs present in the clinical serum sample reacts with HBsAg (ad and ay subtypes) coated onto the assay reaction wells. A HRP-labeled HBsAg conjugate (ad and ay subtypes) then complexes with the bound anti-HBs forming an "antigen sandwich." Unbound materials are removed by washing. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. HRP in the bound conjugate catalyzes the oxidation of the luminol derivative to produce light. The electron transfer agent increases the level and duration of the light produced. The light signals are detected by the system. The amount of HRP conjugate bound is directly proportional to the concentration of anti-HBs antibody present.(Package insert: VITROS Anti-HBs Quantitative Assay, no. GEM1208_US_EN. Ortho-Clinical Diagnostics, Inc; V 13.1, 09/06/2019)

 

Hepatitis B Core Total Antibody:

The VITROS anti-hepatitis B core (anti-HBc) assay is a competitive immunoassay method based on the reaction of anti-HBc in the sample with hepatitis B core antigen (HBcAg)-coated wells. Unbound sample is removed by washing. HRP-labeled antibody conjugate (mouse monoclonal anti-HBc) is then allowed to react with the remaining exposed HBcAg on the well surface. Unbound conjugate is removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the system. The amount of HRP conjugate bound is indicative of the concentration of anti-HBc present in the sample.(Package insert: VITROS Anti-HBc Assay, no. GEM1211_US_EN. Ortho-Clinical Diagnostics, Inc; V 14.1, 09/06/2019)

 

Hepatitis C Virus Antibody:

The VITROS anti hepatitis C virus (anti-HCV) assay is performed using an immunometric technique involving a 2-stage reaction. In the first stage, HCV antibody present in the sample binds to HCV recombinant antigens coated on the reaction wells, and unbound sample is removed by washing. In the second stage, HRP-labeled antibody conjugate (mouse monoclonal antihuman IgG) binds to human IgG captured on the well in the first stage. Unbound conjugate is removed by washing. A reagent containing luminogenic substrates (a luminal derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminal derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The emitted light signals are detected and measured by the system. The amount of HRP conjugate bound is directly proportional to the level of anti-HCV antibodies present in a given sample.(Package insert: VITROS Anti-HCV Assay, no. GEM1243_US_EN. Ortho-Clinical Diagnostics, Inc; V 14.1, 09/06/2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86704

86706

86803

87340

87341 (if appropriate)

87522 (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CRHEP Chronic Hepatitis Profile 92889-5
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
HBC HBc Total Ab, S 13952-7
HB_AB HBs Antibody, S 10900-9
HBSQN HBs Antibody, Quantitative, S 5193-8
H_BAG HBs Antigen, S 5196-1
HCVA4 HCV Ab, S 40726-2

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports